The course catalogue in QV-Compliance A/S has been expanded with a course in IT Validation.

The 2 Day Course is based on GAMP® 5, 21 CFR Part11, EU GMP Annex 11 and Data Integrity.

The Course Participants will be equipped with skills and knowledge to perform a full IT Validation of a Computerized Systems.

For Validation Strategy the V model is used.

Who should participate?

  • Data owners
  • Process owners
  • Project leaders
  • QA
  • Software Suppliers

Course format

The Course is a combination of lecture-style learning and 6 active Workshops.

There will be opportunity to bring issues from your own systems and work with them in the workshops, as well will there be cases and exercises with problems from the real world


Day 1

  • Learning about GAMP®5 and 21 CFR Part11
    • Categorize SW & HW according to GAMP
  • Learning about Data Integrity
  • Science Based Risk Assessment
  • Supplier Assessment
  • Validation Plan
    • Validation approach according to GAMP® 5 categorization
  • Specifications
    • User Requirement Specification
    • Functional Specifications
    • Design Specifications
  • Configuration and Design
  • Development and Review of Software
  • Design review and System Description
  • Workshops

Day 2

  • Testing Computerized System
  • Handover
  • Maintenance
  • Incident, Change and Configuration Management
  • Continuity Plan / Disaster Recovery
  • Retirement of a Computerized System
  • Cloud Solutions
  • Workshops

Participants will receive the presentation, a complete guide, and other useful information.